RecallRadar

FDA Device recall Z-1995-2014

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer

On 2014-07-16 the FDA classified a Class II recall of HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer by Cenorin, citing the temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the p….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1995-2014
ClassificationClass II
Statusterminated
Initiated2013-01-24
Published2014-07-16
Last updated2026-09-13 11:53 UTC
CompanyCenorin
DistributionUS

Product

HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer.

Reason

The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. This caused the water to remain at ambient temperature throughout the pasteurization cycle rather than using hot water.

Identifiers

code_info
610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001,…610601, 610603, 610703, 610704, 610705, 610707, 610708, 610802, 610803, 610804, 610901, 610903, 610904, 610905, 611001, 611002, 611004, 611101, 611102, 611103, 611201, 611202, 611203, 610902L, 611204.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2014%22

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